(62 days)
The INSIGHT Medical FemAssist™ Flexible is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).
The INSIGHT Medical FemAssist™ device consists of a small, flexible, cylindrical, non-sterile device with a short profile which is manufactured from soft silicone material. The FemAssist™ fits over the external female urethral opening, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ is placed directly over the urettral opening where it is held in place by its own mild vacuum action, supporting and reinforcing the natural action of the muscles that control wine output and preventing accidental urine loss. Aquaphor oinment is applied to the device flange area prior to placing it over the urethral opening to help achieve a good seal. The flange area of the FemAssist™ Flexible device is thimer than that of the standard FemAssist™ cleared in K963858 for increased patient comfort.
Here's an analysis of the provided text regarding the acceptance criteria and study for the FemAssist™ Flexible device:
Acceptance Criteria and Device Performance Study
The provided 510(k) summary for the INSIGHT Medical Corp. FemAssist™ Flexible describes a device intended to manage stress urinary incontinence (SUI) in women. The acceptance criteria and supporting studies focus on physical characteristics, safety, and a limited clinical evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
The document doesn't explicitly define quantitative acceptance criteria for the clinical performance, but rather focuses on equivalence to a predicate device and positive patient feedback. For physical characteristics, the acceptance criterion is equivalence to the predicate device.
| Acceptance Criteria Category | Specific Criteria (Implicit/Explicit) | Reported Device Performance |
|---|---|---|
| Physical Characteristics | Tensile strength equivalent to predicate FemAssist™ | Demonstrated equivalence |
| Pull-off force equivalent to predicate FemAssist™ | Demonstrated equivalence | |
| Lift-off pressure equivalent to predicate FemAssist™ | Demonstrated equivalence | |
| Clinical Efficacy | Reduction in urine leakage (quantitative) | 5 out of 14 patients achieved quantitative improvement |
| Patient satisfaction/comfort (subjective) | 2 additional women liked the device, another found it more comfortable (even without full leakage control during strenuous activity) | |
| Overall effectiveness in controlling urine loss (subjective) | 2 remaining patients reported effectiveness | |
| Biocompatibility | Materials identical to predicate device (implied acceptable biocompatibility) | Materials identical to predicate device; no new testing performed |
| Safety | No adverse events reported (implied) | Not explicitly stated, but "safe and effective" conclusion implies no significant safety issues found within the study. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test Set): 14 women.
- Data Provenance: Retrospective (early 1997) market evaluation conducted at the Peakhurst Community Health Centre, Peakhurst, New South Wales, Australia.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical test set. The clinical evaluation primarily relies on quantitative 1-hour pad weight testing and patient self-reporting for subjective feedback.
4. Adjudication Method for the Test Set
The document does not describe any formal adjudication method beyond the quantitative pad weight testing and subjective patient reports. There's no mention of expert consensus or arbitration for ambiguous cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted for this device. The evaluation was a clinical market evaluation with patients.
6. Standalone (Algorithm Only) Performance Study
No. This device is a physical medical device, not an algorithm or AI. Therefore, a standalone (algorithm only) performance study was not applicable and not performed.
7. Type of Ground Truth Used (Clinical Test Set)
The ground truth for the clinical test set was a combination of:
- Quantitative Outcome Data: Reduction in urine leakage measured by 1-hour pad weight testing.
- Patient-Reported Outcomes (PROs): Subjective feedback on comfort, liking the device, and perceived effectiveness in controlling urine loss.
8. Sample Size for the Training Set
The document does not mention a separate "training set" in the context of device development or clinical evaluation. The initial "standard" FemAssist™ device (K963858) would have undergone its own development and testing, which might be considered an ancestral "training" for the modified Flexible version, but no specific data is provided. This device is a physical product, not an AI/ML algorithm that typically uses training datasets.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set in the context of AI/ML, this question is not applicable to the information provided for this medical device. The "ground truth" for the predicate standard FemAssist™ would have been established via its own development and clinical evaluation processes, which are not detailed in this submission for the modified Flexible device.
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INSIGHT Medical Corp. 510(k) Premarket Notification December 10, 199
510(k) Summary
81092
FEB 12 1998
Pursuant to 512(i)(3)(A) of the Food, Drug and Cosmetic Act, INSIGHT Medical Corp. is required to submit with this Premarket Notification either an " ... adequate summary of any information respecting safety and effectiveness or state that information will be made available upon request of any person." INSIGHT Medical chooses to submit a summary of the safety and effectiveness information. The summary is as follows:
| Trade Name: | FemAssist™ Flexible |
|---|---|
| Owner/Operator: | INSIGHT Medical Corporation580 Main StreetBolton, MA 01740Registration # 1221923 |
| Device Generic Name: | Urethral clamp |
| Classification: | According to Section 513 of the Federal Food, Drug, andCosmetic Act, the device is considered "unclassified." Urethral clamps areaddressed in 21 CFR 876.5160. The FemAssist™ product code is 78MNG. |
| Predicate Device: | FemAssist™Manufactured and Distributed by:INSIGHT Medical Corp.580 Main StreetBolton, MA 01740K963858 |
Product Description:
The INSIGHT Medical FemAssist™ device consists of a small, flexible, cylindrical, non-sterile device with a short profile which is manufactured from soft silicone material. The FemAssist™ fits over the external female urethral opening, between the labia, posterior to the clitoris and anterior to the vagina. The FemAssist™ is placed directly over the urettral opening where it is held in place by its own mild vacuum action, supporting and reinforcing the natural action of the muscles that control wine output and preventing accidental urine loss. Aquaphor oinment is applied to the device flange area prior to placing it over the urethral opening to help achieve a good seal. The flange area of the FemAssist™ Flexible device is thimer than that of the standard FemAssist™ cleared in K963858 for increased patient comfort.
Indications for Use:
The FemAssist™ Flexible is an external female continence device indicated for the management of urinary leakage in women suffering from stress urinary incontinence (SUI).
Blocompatibility:
The FemAssist™ Flexible device will be manufactured from materials identical to those used in the FemAssist™ standard device; therefore, no biocompatibility testing was performed in support of this submission.
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Safety and Performance:
The following safety and performance tests were performed on the FemAssist™ Flexible:
-
- Tensile test
- Pull-off Test 2.
- Lift-off Pressure Test 3.
The results of this testing demonstrated that the physical characteristics of the modified FemAssist™ device are equivalent to those of the currently marketed FemAssist™.
Clinical Testing:
Market evaluation testing was performed at the Peakhurst community Health Centre, Peakhurst, New South Wales. Australia in early 1997. A total of 14 women evaluated the Flexible device. Of these 14, 4 patients withdrew from the study. Five of the 14 achieved a quantitative improvement as measured by a reduction in wine leakage during 1-hour pad weight testing. Two additional women reported that they liked the FemAssist™ Flexible device even though they did not achieve a quantitative improvement in the pad weight testing. The remaining patient, a very active athlete, found the Flexible device to be more comfortable than the "standard" FemAssist™, but did not feel that her leakage was well controlled while sprinting and cycling with either device. She did report success with the FemAssist™ while jogging. Subjective, non-quantitative data was presented for the remaining two reported that the FemAssist™ Flexible device was effective in controlling urine loss.
Conclusion:
Based on the indications for use, technological characteristics and performance testing, the INSIGHT Medical FemAssist™ Flexible has been shown to be safe and effective for its intended use.
048
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR 2 6 2010
INSIGHT Medical Mr. Michael Vergano Director of Product Development/Operations 580 Main Street BOLTON MA 01740
Re: K974645
Trade/Device Name: FemAssistTMFlexible Continence Device Regulation Number: 21 CFR& 876.5160 Regulation Name: Urological clamp for males Regulatory Class: I Product Code: MNG Dated: December 10, 1997 Received: December 12, 1997
Dear Mr. Michael Vergano:
This letter corrects our substantially equivalent letter of February 12, 1998.
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 Mr. Michael Vergano K974645
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safetv/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris
Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page __ 1__ of ___ 1
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: _ INSIGHT Medical FemAssist™ Flexible
Indications for Use:
The INSIGHT Medical FemAssist™ Flexible is an external female continence The INSTOFT Medical For the nanagement of urinary leakage in women suffering from stress urinary incontinence (SUI).
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Stirling
(Division Sign-Off) Division of Reproductive, Abdominat EN !... ------and Radiological Devices
510(k) Number K974641
Prescription Use V (Per 21 CFR 801.109) OR
Over-the -Counter Use _
001
C
§ 876.5160 Urological clamp.
(a)
Identification. A urological clamp for males is a device used to close the urethra of a male to control urinary incontinence or to hold anesthetic or radiography contrast media in the urethra temporarily. It is an external clamp.(b)
Classification. Class I (general controls). Except when intended for internal use, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.